Facts About COVID-19 Vaccines

Facts About COVID-19 Vaccines

Approved and Authorized Vaccines

Below are the vaccines that are approved and authorized in the United States to prevent COVID19:

Vaccine Brand Name

FDA

approval/authorization

status

?

Pfizer-BioNTech/

Cominarity

PfizerBioNTech pediatric covid19 vaccine for children aged 5

-11 [3]

Moderna

Johnson & Johnson/

Janssen

?

Who can get

this

vaccine?[1]

How many shots will

you need?

When are you

fully

vaccinated?

People 12

years and

older

2 shots

Given 3 weeks (21

days) apart [ 2]

2 weeks after

your second

shot

Children

aged 5 ¨C 11

years

2 shots

Given 3 weeks (21

days) apart [ 2]

2 weeks after

your second

shot

Emergency Use

Authorization/ EUA

People 18

years and

older

2 shots

Given 4 weeks (28

days) apart [ 2]

2 weeks after

your second

shot

People 18

years and

older

1 shot

Emergency Use

Authorization/ EUA

2 weeks after

your shot

Full approval for

individuals 16 and

older

Emergency Use

Authorization

(EUA) for

individuals aged

12 ¨C15, and 3rd

booster

Emergency Use

Authorization

(EUA)

1

If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction to any ingredient

in the vaccine you are scheduled to receive, you should not get that vaccine. If you have been instructed

not to get one type of COVID-19 vaccine, you may still be able to get another type. Learn more information

for people with allergies.

2 You should get your second shot as close to the recommended 3-week or 4-week interval as possible.

However, your second shot may be given up to 6 weeks (42 days) after the first dose, if necessary.

3 Children 5 through 11 years old will receive a separate vaccine formulation of the Pfizer-BioNTech COVID19 Vaccine that has one-third the dose given to adolescents and adults.

This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.

Booster doses: 1

Vaccine brand

name

FDA approval/ authorization

status

Eligible population

When can you get the

booster shot?

You should get a

booster if you are 18

years or older.

Pfizer-BioNTech

6 months after

completion of the

primary 2-dose series.

Emergency Use Authorization/

EUA

You should get a

booster if you are 18

years or older.

Moderna

Johnson &

Johnson/

Janssen

6 months after

completion of the

primary 2-dose series.

Emergency Use Authorization/

EUA

Emergency Use Authorization/

EUA

You should get a

booster if you are 18

years or older.

2 months after

completion of the

single-dose primary

regimen

1

FDA has also authorized the use of heterologous (or ¡°mix and match¡±) booster dose for

currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. COVID-19 vaccines can

be administered as a heterologous (or ¡°mix and match¡±) booster dose in eligible individuals

following completion of primary vaccination with a different available COVID-19 vaccine.

Data Supporting Need for a Booster Shot

Studies show after getting vaccinated against COVID-19, protection against the virus and the

ability to prevent infection with the variants may decrease over time.

Although COVID-19 vaccination remains effective in preventing severe disease, recent data

suggest vaccination becomes less effective over time, especially in people aged 65 and older and

at preventing infection or milder illness with symptoms.

This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.

The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of

vaccination, boosters, and prevention efforts needed to protect against COVID-19. Early data from

South Africa suggest increased transmissibility of the Omicron variant and the potential for

immune evasion.

Emerging evidence also shows that among healthcare and other frontline workers, vaccine

effectiveness against COVID-19 infection is also decreasing over time.

This lower effectiveness is likely due to the combination of decreasing protection as time passes

since getting vaccinated, as well as the greater infectiousness of the Delta variant.

Data from clinical trials showed that a booster shot increased the immune response in trial

participants who finished a Pfizer-BioNTech or Moderna primary series 6 months earlier or who

received a J&J/Janssen single-dose vaccine 2 months earlier. With an increased immune response,

people should have improved protection against COVID-19, including the Delta variant. For PfizerBioNTech and J&J/Janssen, clinical trials also showed that a booster shot helped prevent COVID-19

with symptoms.

This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.

COVID-19 Vaccine Dosage and Administration

Vaccine type

Age of

recipient

5 ¨C 11 years

Vial cap color

denoting

formulation

Orange

Concentration

of mRNA/viral

particles per

primary dose

10 ?g (1)

PfizerBioNTech

12 ¨C 17 years

Purple

30 ?g(2)

PfizerBioNTech

Interval

between last

primary to

booster dose

Concentration

of mRNA per

booster dose

Not

recommended

Not applicable

Not

recommended

Not applicable

¡Ý18 years

Purple

30 ?g(2)

¡Ý6 months

30 ?g

¡Ý18 years

Not applicable

100 ?g

¡Ý6 months (3)

50 ?g

¡Ý18 years

Not applicable

5¡Á1010 viral

particles

PfizerBioNTech

Moderna

J&J/ Janssen

(1)

(2)

(3)

¡Ý2 months

5¡Á1010 viral

particles

The Pfizer-BioNTech vaccine for children ages 5 through 11 years has the same active ingredients

as the vaccine given to adults and adolescents. However, children ages 5 through 11 years cannot

get the Pfizer-BioNTech COVID-19 Vaccine given to adults and adolescents. In addition, children

ages 5 through 11 years receive an age-appropriate dose that is one-third of the adult dose of

Pfizer-BioNTech COVID-19 vaccine. Smaller needles, designed specifically for children, are also

used for children ages 5 through 11 years.

Adolescents ages 12 years and older receive the same dosage of Pfizer-BioNTech COVID-19

vaccine as adults.

Booster dose for Moderna is only half the primary dose (50 ?g).

This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.

What is an Emergency Use Authorization (EUA)?

The United States FDA has made the COVID-19 vaccines available under an emergency access

mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services

(HHS) declaration that circumstances exist to justify the emergency use of drugs and biological

products during the COVID-19 pandemic.

EUA approved products have not undergone the same type of review as an FDA-approved or

cleared product. FDA may issue an EUA when certain criteria are met, which includes that there

are no adequate, approved, and available alternatives. In addition, the FDA decision is based on

the totality of scientific evidence available showing that the product may be effective to prevent

COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product

outweigh the known and potential risks of the product. All of these criteria must be met to allow

for the product to be used during the COVID-19 pandemic.

The EUA for COVID-19 vaccines are in effect for the duration of the COVID-19 declaration justifying

emergency use of these products, unless terminated or revoked (after which the products may no

longer be used).

How Can a Vaccine Get FDA Approval?

After the three phases of clinical trials are complete, the vaccine manufacturer must present data to an

FDA review team that proves the vaccine is safe and effective and that its benefits outweigh any risks.

Once a vaccine is approved, it must be properly labeled with its risks and benefits, as well as its correct use,

so health care providers can share this information with their patients.

Before an approved vaccine can get distributed to the public, the manufacturer must test all batches of the

vaccine, called lots, for safety, potency and purity. The FDA reviews this information before the lots can be

released. The FDA also routinely inspects the facilities where the vaccines are produced to ensure the

product¡¯s safety and quality. The Pfizer vaccine has finished and passed this rigorous process.

FACT: COVID-19 vaccines will not give you COVID-19

None of the COVID-19 vaccines currently in development or in use in the United States, containthe live

virus that causes COVID-19. There are several different types of vaccines in development, and the goal for

each of them is to ¡®teach¡¯ our immune systems how to recognizeand fight the virus that causes COVID-19.

Sometimes teaching the immune system can cause symptoms such as fever. These symptoms are normal

and are a sign that the body is building immunity. Learn more about how COVID-19 vaccines work.

It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible a

person could be infected and get sick with the virus that causes COVID-19 just beforeor just after

vaccination. This is because the body has not had enough time to react to the vaccine to provide

protection.

This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.

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